SleepNCT07612111
Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents
A study testing Transdiagnostic Intervention for Sleep and Circadian Dysfunction in people with Sleep and Autism Spectrum Disorder, run by Milton S. Hershey Medical Center.
Trial summary
Sleep and circadian problems are associated with deleterious social, emotional, and cognitive outcomes, yet are modifiable. This prospective study will adapt and optimize an empirically supported behavioral intervention that addresses common sleep and circadian problems of autistic adolescents, who are at increased… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Sleep, Autism Spectrum Disorder, Transdiagnostic
- What is being tested?
- Transdiagnostic Intervention for Sleep and Circadian Dysfunction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Autistic adolescents diagnosed with Autism Spectrum Disorder (ASD).
- Between the ages of 13 and 17 years.
- English-speaking
- Sufficient verbal communication skills to participate in interviews, surveys, or tasks.
- Ability to provide informed assent with guardian consent.
- One or more sleep or circadian problem(s) for a period of at least 3 months assessed with the Sleep and Circadian Problems Interview.
Who cannot join
- A history of Intelligent Quotient (IQ) < 70.
- A history of psychotic, bipolar or seizure disorders as per medical record.
- Untreated sleep apnea, a history of narcolepsy, or restless legs syndrome, as per structured interview based on risk screeners.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Sleep and circadian problems are associated with deleterious social, emotional, and cognitive outcomes, yet are modifiable. This prospective study will adapt and optimize an empirically supported behavioral intervention that addresses common sleep and circadian problems of autistic adolescents, who are at increased risk for mental health disorders, using a transdiagnostic approach. The knowledge gained from this study will help to address a critical need for accessible transdiagnostic sleep interventions for autistic adolescents, who experience a broad range of sleep and circadian problems at high rates and often lack access to specialty care treatment.
- Conditions
- Sleep, Autism Spectrum Disorder, Transdiagnostic
- Being tested
- Transdiagnostic Intervention for Sleep and Circadian Dysfunction
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiagnostic Intervention for Sleep and Circadian DysfunctionBehavioural
Also called TranS-C
Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C). This evidence-based intervention targets psychosocial, behavioral, and cognitive processes that maintain sleep and circadian problems. The 4 Core Modules are: establishing regular sleep-wake times and routines; improving daytime functioning; correcting unhelpful sleep-related beliefs; and maintenance of behavior change. The optional Modules are: improving sleep efficiency; reducing time in bed; dealing with delayed or advanced phase; reducing sleep-related worry/vigilance; and negotiating sleep in a complicated environment and reducing nightmares. TranS-C consists of a total of 6, 50-min sessions over six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Transdiagnostic Sleep and Circadian Intervention | Experimental | Not described Receives: Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional sleep health (MSH) score
Multidimensional Sleep Health (MSH) score, a composite index summarizing six sleep dimensions: regularity, satisfaction, alertness, timing, efficiency, and duration. Each dimension is classified as optimal (1) or suboptimal (0) using prespecified cutoffs: Regularity: standard deviation of sleep midpoint and total sleep time from actigraphy less than 60 minutes; Satisfaction: average self-reported ratings of sleep satisfaction (from the Insomnia Severity Index) and 'rested upon awakening' from sleep diary in the 'moderately' to 'extremely' satisfied/rested range; Alertness: Epworth Sleepiness Scale total score less than or equal to 9; Timing: average sleep midpoint from actigraphy between 02:00 and 04:00; Efficiency: average sleep efficiency from actigraphy at least 85%; Duration: average total sleep time from actigraphy between 7 and 9 hours. Dimension scores are summed to yield a total MSH score from 0 to 6, with higher scores indicating better overall sleep health.
Measured: baseline (pretreatment)
Multidimensional sleep health (MSH) score
Multidimensional Sleep Health (MSH) score, a composite index summarizing six sleep dimensions: regularity, satisfaction, alertness, timing, efficiency, and duration. Each dimension is classified as optimal (1) or suboptimal (0) using prespecified cutoffs: Regularity: standard deviation of sleep midpoint and total sleep time from actigraphy less than 60 minutes; Satisfaction: average self-reported ratings of sleep satisfaction (from the Insomnia Severity Index) and 'rested upon awakening' from sleep diary in the 'moderately' to 'extremely' satisfied/rested range; Alertness: Epworth Sleepiness Scale total score less than or equal to 9; Timing: average sleep midpoint from actigraphy between 02:00 and 04:00; Efficiency: average sleep efficiency from actigraphy at least 85%; Duration: average total sleep time from actigraphy between 7 and 9 hours. Dimension scores are summed to yield a total MSH score from 0 to 6, with higher scores indicating better overall sleep health.
Measured: posttreatment (up to 6 weeks post baseline)
Secondary outcomes (6)
Enrollment rate (feasibility)
Number of participants enrolled per month over the planned recruitment period; calculated as total number enrolled divided by number of recruitment months.
Measured: up to 6 months
Participants retention rate (feasibility)
Percentage of enrolled participants who complete the final session (6 sessions). Calculated as the number who complete the final visit divided by the number enrolled, multiplied by 100.
Measured: from enrollment to session 6 (up to 6 months)
Therapist Evaluation Questionnaire (TEQ) Total Score at End of Treatment
Scores on Therapy Evaluation Questionnaire (TEQ). TEQ is a 7-item self-report scale rated 1-7, with higher scores indicating greater treatment credibility, willingness to participate, and perceived therapist warmth/competence; total score is the sum (range 7-49) or mean of all items, with higher scores reflecting more positive evaluation of therapy and therapist.
Measured: posttreament (up to 3 months from baseline)
Therapy Homework Completion Rate
Percentage of between-session therapy homework assignments completed by each retained participant. For each participant, the number of homework assignments reported as completed is divided by the number of homework assignments assigned during the treatment period, multiplied by 100 to yield a percentage. Higher percentages indicate greater adherence to assigned homework.
Measured: from first session to posttreament (up to 3 months from baseline)
Treatment Session Completion Rate
Percentage of retained participants who complete all scheduled treatment sessions. The number of retained participants who attend (or complete) every scheduled treatment session during the treatment period is divided by the total number of retained participants, multiplied by 100 to yield a percentage. Higher percentages indicate greater engagement with the treatment.
Measured: from first session to posttreament (up to 3 months from baseline)
Treatment Fidelity: Therapist Strategy Use
Percentage of prescribed TranS-C treatment strategies recorded as used on the therapist-reported fidelity checklist. For each session, therapists indicate which TranS-C strategies were delivered using a standardized checklist; the number of strategies marked as used is divided by the total number of strategies listed on the checklist, multiplied by 100 to yield a session-level fidelity percentage. Higher percentages indicate greater adherence to the TranS-C treatment protocol.
Measured: from first session to posttreament (up to 3 months from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Kristina Lenker, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612111
- Sponsor's protocol ID
- 27612
- Status last verified
- Oct 2026
- First submitted
- 21 May 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) collected for primary and secondary outcome measures-including Multidimensional Sleep Health (MSH) scores, Insomnia Severity Index (ISI) scores, Epworth Sleepiness Scale (ESS) scores, actigraphy-derived sleep parameters (duration, efficiency, timing, regularity), therapy engagement metrics (e.g., session attendance rate, homework completion rate), treatment fidelity data (TranS-C checklist adherence), and feasibility indicators (enrollment rate, retention rate)-will be made available. Accompanying materials will include the study protocol, statistical analysis plan, informed consent form (redacted), and codebooks defining all variables and scoring algorithms (e.g., MSH composite derivation).
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents
- ClinicalTrials.gov ID
- NCT07612111
- Acronym / sponsor ID
- 27612
- Conditions
- Sleep, Autism Spectrum Disorder, Transdiagnostic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sleep and circadian problems are associated with deleterious social, emotional, and cognitive outcomes, yet are modifiable. This prospective study will adapt and optimize an empirically supported behavioral intervention that addresses common sleep and circadian problems of autistic adolescents, who are at increased risk for mental health disorders, using a transdiagnostic approach. The knowledge gained from this study will help to address a critical need for accessible transdiagnostic sleep interventions for autistic adolescents, who experience a broad range of sleep and circadian problems at high rates and often lack access to specialty care treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transdiagnostic Sleep and Circadian Intervention | Experimental | Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Autistic adolescents diagnosed with Autism Spectrum Disorder (ASD).
- Between the ages of 13 and 17 years.
- English-speaking
- Sufficient verbal communication skills to participate in interviews, surveys, or tasks.
- Ability to provide informed assent with guardian consent.
Key exclusion criteria (3 listed)
- A history of Intelligent Quotient (IQ) < 70.
- A history of psychotic, bipolar or seizure disorders as per medical record.
- Untreated sleep apnea, a history of narcolepsy, or restless legs syndrome, as per structured interview based on risk screeners.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdiagnostic Intervention for Sleep and Circadian DysfunctionAlso: TranS-CTransdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C). This evidence-based intervention targets psychosocial, behavioral, and cognitive processes that maintain sleep and circadian problems. The 4 Core Modules are: establishing regular sleep-wake times and routines; improving daytime functioning; correcting unhelpful sleep-related beliefs; and maintenance of behavior change. The optional Modules are: improving sleep efficiency; reducing time in bed; dealing with delayed or advanced phase; reducing sleep-related worry/vigilance; and negotiating sleep in a complicated environment and reducing nightmares. TranS-C consists of a total of 6, 50-min sessions over six weeks. | Behavioural | Transdiagnostic Sleep and Circadian Intervention |
Primary outcome
Multidimensional sleep health (MSH) score
Time frame: baseline (pretreatment)
Multidimensional Sleep Health (MSH) score, a composite index summarizing six sleep dimensions: regularity, satisfaction, alertness, timing, efficiency, and duration. Each dimension is classified as optimal (1) or suboptimal (0) using prespecified cutoffs: Regularity: standard deviation of sleep midpoint and total sleep time from actigraphy less than 60 minutes; Satisfaction: average self-reported ratings of sleep satisfaction (from the Insomnia Severity Index) and 'rested upon awakening' from sleep diary in the 'moderately' to 'extremely' satisfied/rested range; Alertness: Epworth Sleepiness Scale total score less than or equal to 9; Timing: average sleep midpoint from actigraphy between 02:00 and 04:00; Efficiency: average sleep efficiency from actigraphy at least 85%; Duration: average total sleep time from actigraphy between 7 and 9 hours. Dimension scores are summed to yield a total MSH score from 0 to 6, with higher scores indicating better overall sleep health.
Multidimensional sleep health (MSH) score
Time frame: posttreatment (up to 6 weeks post baseline)
Multidimensional Sleep Health (MSH) score, a composite index summarizing six sleep dimensions: regularity, satisfaction, alertness, timing, efficiency, and duration. Each dimension is classified as optimal (1) or suboptimal (0) using prespecified cutoffs: Regularity: standard deviation of sleep midpoint and total sleep time from actigraphy less than 60 minutes; Satisfaction: average self-reported ratings of sleep satisfaction (from the Insomnia Severity Index) and 'rested upon awakening' from sleep diary in the 'moderately' to 'extremely' satisfied/rested range; Alertness: Epworth Sleepiness Scale total score less than or equal to 9; Timing: average sleep midpoint from actigraphy between 02:00 and 04:00; Efficiency: average sleep efficiency from actigraphy at least 85%; Duration: average total sleep time from actigraphy between 7 and 9 hours. Dimension scores are summed to yield a total MSH score from 0 to 6, with higher scores indicating better overall sleep health.
6 secondary outcomes
Enrollment rate (feasibility)
Time frame: up to 6 months
Participants retention rate (feasibility)
Time frame: from enrollment to session 6 (up to 6 months)
Therapist Evaluation Questionnaire (TEQ) Total Score at End of Treatment
Time frame: posttreament (up to 3 months from baseline)
Therapy Homework Completion Rate
Time frame: from first session to posttreament (up to 3 months from baseline)
Treatment Session Completion Rate
Time frame: from first session to posttreament (up to 3 months from baseline)
Treatment Fidelity: Therapist Strategy Use
Time frame: from first session to posttreament (up to 3 months from baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) collected for primary and secondary outcome measures-including Multidimensional Sleep Health (MSH) scores, Insomnia Severity Index (ISI) scores, Epworth Sleepiness Scale (ESS) scores, actigraphy-derived sleep parameters (duration, efficiency, timing, regularity), therapy engagement metrics (e.g., session attendance rate, homework completion rate), treatment fidelity data (TranS-C checklist adherence), and feasibility indicators (enrollment rate, retention rate)-will be made available. Accompanying materials will include the study protocol, statistical analysis plan, informed consent form (redacted), and codebooks defining all variables and scoring algorithms (e.g., MSH composite derivation).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Transdiagnostic Intervention for Sleep and Circadian Dysfunction in people with Sleep and Autism Spectrum Disorder, run by Milton S. Hershey Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristina P Lenker, PhD (7175310003 ext. 280299, klenker2@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional sleep health (MSH) score (time frame: baseline (pretreatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.